Cefadroxil monohydrate, powder

Characteristics:
A crystalline powder

Application:
The product is suitable for the manufacture of granules for suspensions, dry powder mixtures for syrups and tablets. The appropriate excipients should be added.

Therapeutical category:
Oral broad spectrum cephalosporin.

Pharmacopoeia quality:
- USP
- Ph.Eur.
- BP
latest editions

Regulatory information:
EU: EDQM
Taiwan: Department of Health
USA: FDA
India: Ministry of Health and Family Welfare

Packaging & shipping:
quantity per package: 25 kgs
approx. gross weight: 27.2 kgs
quantity per pallet: 300 kgs
approx. gross weight: 338 kgs

One polyethylene bag in aluminium bag in a 70 ltr double carton box
box size (l x w x h) = 39 x 39 x 49.5 cm
pallet loaded l x w x h = 120 x 80 x 114 cm
12 drums ( 2 layers of 6)

Appearance:
White or almost white crystalline powder.

Content (HPLC):
"on dry": 95.0 - 102 .0%.

Absorbance (Ph.Eur.):
264 nm: 225 - 250.
330 nm: ≤ 0.05.

pH:
4.0 - 6.0.

Water (Karl Fischer):
4.2 - 6.0%.

Dimethylaniline:
Absent.

Bulk density (USP):
0.55 - 0.65 g/ml.

Shelf-life:
Minimum 4 years in the original packaging under 'storage conditions'.

Storage conditions:
Below 25 ºC, protected from light and moisture.